Cleared Traditional

K931721 - IL TEST FIBRINOGEN-C

K931721 is an FDA 510(k) clearance for IL TEST FIBRINOGEN-C, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K931721 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
128d
Days
Class 2
Risk

K931721 is an FDA 510(k) clearance for the IL TEST FIBRINOGEN-C. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 13, 1993 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K931721

510(k) Number K931721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1993
Decision Date August 13, 1993
Days to Decision 128 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 113d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQJ Device Classification - Class 2, Special Controls

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KQJ System, Fibrinogen Determination

All 27
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K931721.
FIF TM
K970189 · Panbio, Inc. · May 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · Crestat Diagnostics, Inc. · Apr 1997
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994
FIBRINOGEN RID TEST KIT
K922416 · The Binding Site, Ltd. · Mar 1993
MULTIFIBREN
K925988 · Behring Diagnostics, Inc. · Mar 1993
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · International Technidyne Corp. · Sep 1992